The Public Information Officer ( Dr. D.K. Sharma )
Medical Superintendent,
Ground Floor, MS Wing, AIIMS
New Delhi 110024

 

Sub: Application under Right to Information Act 2005

 

Please provide the following information under Right to Information Act 2005:

 

  1. Please provide the details that since 1st January 2003 , if any drug tested during clinical trials in Pediatrics Dpt. of AIIMS is not available in India but available in any other country or international market. Please provide the name of the drug, name of manufacturer, country of origin along with the reason that why the same drug is not available in Indian Market if tested in Pediatrics Dpt. of AIIMS , Delhi, India.

 

  1. Please provide complete list of the medicine or drug used during clinical trails on human babies made outside of India by Department of Pediatrics Since 1st January 2006 as per following details:-

 

 

  1. Is any of the drug used in clinical trials since 1st Jan 2006 is already available in the Indian Market under any brand name which is not part of current clinical trials ? Please name the same and reason to include the same drug if the same is already available in India ?

 

  1. What are the top 10 side effects noted in the period of clinical on Human Babies by Dpt. Of Pediatrics since 1st January, 2006?

 

  1. Please provide total number of the babies who had side effects due to clinical trials since 1st Jan 2006 . Please also provide details how many of them had serious side effects and how many had mild side effects ?

 

  1. Name the top 10 medicine which caused side effects (serious & mild) on the babies , Please also provide the data related to the side effects of the same drugs while usage of the same in the country of origin of the drug.

 

  1. Is it necessary to take approval from Drugs Controller General , Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Government of India  before conducting any clinical trials in India ( Here we are not asking for Clinical Trial’s Site approval but about approval of the individual studies of clinical trials) ? If yes, did Department of Pediatrics take the necessary approval from Drugs Controller General, CDSCO? Please provide approval reference numbers of the clinical trials conducted by department of pediatrics since 1st January , 2006 ?

 

  1. Please name all the sponsors & collaborators of Clinical Trials conducted by Department of Pediatrics Since 1st Jan 2006 and their country of their origin ?

 

  1. Please provide following data related to Top five Clinical Trials ( in terms of maximum number of Human Babies used who were under 1 year of age at the time of entering into clinical trials )

 

a)       Name of the Drug(s)

b)       Regulatory status of the drug in other countries (Names of countries where the drug is approved along with international package insert or where IND application is filed)

c)       Objective of the Study

d)        Phase of Study

e)        Names of  the Participating Countries /Investigator sites

f)         Total no. of  patients to be enrolled globally

g)       No. of patients to be included in India

h)        Regulatory/ IRB approvals from participating countries

i)         Status of the study in other countries : this should include no. of patients enrolled, no. patients completed the study and no. of  patients discontinued & no. patient died.

j)         Suspected Unexpected  Serious Adverse Reaction (SUSAR) from other participating countries if any reported

k)       Is any study has  been discontinued in any country and in case of discontinuation the reasons for such a discontinuation .

l)         Animal Pharmacology Data & Toxicology Data

m)     Clinical Data

1.       Phase I

2.       Phase II

3.       Phase III

4.       Phase IV

 

  1.  Please provide study brief of all clinical trials conducted by department of pediatric since 1st January 2006 till date including following details :-

 

a)       Disease Profile

b)       Study Brief : Including Condition, Intervention & Phase.

c)       Study Objective: Primary & Secondary.

d)       Inclusion & Exclusion Criteria

 

 

I am separately depositing Rs.10   as application fee.

 The information sought for in required to be supplied in printed form.

 I am a bona fide citizen of India and owe allegiance to the sovereignty, unity and integrity of India and have not voluntarily acquired the citizenship of another country.

  

Yours sincerely,

 

Rahul Verma

Managing Trustee

Uday Foundation for Congenital Defects and Rare Blood Groups

89-F/K , Sheikh Sarai – II , New Delhi 110017

Email : info@uday.org.in  

URL : www.uday.org.in   & www.rarebloodgroups.org

Phone : 9811110088

 

Date : 22/08/2008

Place : New Delhi